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Reference.org
First-in-class medication
open-in-new
<p>A first-in-class medication is a <a href="/facts/Prototype_drug/mwlfAHdd">prototype drug</a> that uses a "new and unique mechanism of action" to treat a particular medical condition. While the <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration's</a> <a href="/facts/Center_for_Drug_Evaluation_and_Research/GXmqIjAk">Center for Drug Evaluation and Research</a> tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category. Although many first-in-class medications qualify as <a href="/facts/Breakthrough_therapy/VYNK0Ve6">breakthrough therapies</a>, <a href="/facts/Regenerative_Medicine_Advanced_Therapy/4rSd8Xl4">Regenerative Medicine Advanced Therapies</a> and/or <a href="/facts/Orphan_drug/96judAS6">orphan drugs</a>, first-in-class status itself has no regulatory effect. </p>